BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
Received Jun 2, 2026 · Event occurred Apr 30, 2026
Report 0001313525-2026-00063 · MDR key 25368663
Device
Generic name
Folders And Injectors, Intraocular Lens (iol)
Manufacturer
Bausch + LombModel number
BLIS-X1Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
63 YR · Unknown
- Corneal Edema
- Inflammation
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION OF THIS EVENT IS ONGOING AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem
IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE HAPTIC WAS TORN. THE INCISION WAS ENLARGED AND A DIFFERENT MODEL IOL WAS IMPLANTED. A SUTURE WAS USED TO HELP CLOSE THE WOUND. POST-OPERATIVELY THE PATIENT WAS DIAGNOSED WITH CORNEAL EDEMA AND INFLAMMATION, HOWEVER ACCORDING TO THE SURGEON THE PATIENT IS IMPROVING. IN THE SURGEON¿S OPINION THE MOST LIKELY CAUSE OF THE EVENT IS THE MANNER LENS WAS LOADED INTO THE CARTRIDGE BY THE SCRUB TECH.